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Compliance Systems Analyst I

Indianapolis, IN 46256

Posted: 12/02/2022 Job Number: 67645

Job Description

Can be worked 100% remotely

Initial duration: 1 year

Training period of 6 months

Possibility of conversion 

Responsibilities include:

-Evaluate complaints and determine if a medical device report (MDR) is needed per FDA regulations 21 CFR 803 and Roche procedures.

-Where a report is not needed provide a detailed and compliant rationale

-Where a report is needed, complete the MDR form in the case handling IT tool and submit for review and approval.

Minimum 3 years pathology/hospital laboratory experience or 3 years working as a healthcare professional (nurse, physician assistant) required

-Attention to detail
-Critical thinking skills a must
-Excellent writing skills
-Ability to work with minimal supervision
-Knowledge of FDA Regulations, including 21 CFR 803 is a plus

Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

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Ric D'Arcangelis

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